Therapeutic Hydrogel

Product NDC
78863-1090
11-digit product format
788631090
Labeler code
78863
Product ID
78863-1090_527a729b-d26e-4543-bb3f-3b82e116b0a1
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
CREAM
Route
TOPICAL
Labeler
Noon Aesthetics M.R. Ltd
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-01
Substance
SALICYLIC ACID
Active strength
1 g/50g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Therapeutic Hydrogel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID1 g/50g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
317152Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cfe76456-0a4c-4dd8-b060-af9d109fb9b9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78863-1090-1Therapeutic Hydrogel50 g in 1 BOTTLE, DISPENSINGCREAM504
78863-1090-1Therapeutic Hydrogel1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78863-1090THERAPEUTIC HYDROGEL (SALICYLIC ACID) CREAM [NOON AESTHETICS M.R. LTD]3Current NDC, Legacy NDC, 2 package rows20240125_cfe76456-0a4c-4dd8-b060-af9d109fb9b9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 47 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Peace Out AcneSALICYLIC ACIDPeace Out LLC.eac771e2-4c1a-3808-e053-2995a90ac5fc2024-05-20WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Pore Clearing Acne CleanserSALICYLIC ACIDGalderma Laboratories, L.P.fc3abc75-5d9a-4b77-9b61-e6beba8a5cfe2024-05-09WarningsExact identifier
application number: M006
Walgreens Creamy Acne Face Wash Acne MedicationBENZOYL PEROXIDEWalgreen Company13e5396b-839b-4c08-a98f-f0a36c9a0bff2024-05-09WarningsExact identifier
application number: M006
Bubble Knock Out Acne Spot TreatmentSALICYLIC ACIDBUBBLE BEAUTY17cf44cf-55f1-86a5-e063-6294a90a35d22024-05-06WarningsExact identifier
application number: M006
Bubble Super Clear Blemish Prevention SerumSALICYLIC ACIDBUBBLE BEAUTY1790ad12-c947-ddc0-e063-6394a90a85692024-05-03WarningsExact identifier
application number: M006
Walgreens Daily Acne Cleanser- Sensitive Skin FormulaBENZOYL PEROXIDEWalgreen Companyacae5006-e647-4f00-b93a-2c0bceee14cb2024-05-01WarningsExact identifier
application number: M006
Derma E Acne Blemish Control Treatment SerumSALICYLIC ACIDderma ebf5f489d-07c6-47b8-ae76-701e7ad92e8d2024-04-30WarningsExact identifier
application number: M006
Pacifica Clear Mist Facial AcneSALICYLIC ACIDPacifica Beauty, LLC16ee1a80-d523-1d02-e063-6394a90a94592024-04-25WarningsExact identifier
application number: M006
Benzoyl PeroxideBENZOYL PEROXIDEBurel Pharmaceuticals, LLC0617d42d-511d-4c1a-a919-b37abbc14efc2024-04-24WarningsExact identifier
application number: M006
Blemish DotsSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.f3cd004d-32f1-4888-8129-d355a4750b252024-03-24WarningsExact identifier
application number: M006
Lacura Blemish Dots Conceal and TreatSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.15c447b5-0e51-43e7-b697-683bc0e686c02024-03-20WarningsExact identifier
application number: M006
My Beauty Spot Acne BusterSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.c61e100b-a141-45b3-842b-855be28b02262024-03-20WarningsExact identifier
application number: M006
My Beauty Spot Acne BusterSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.f5c5a2df-11c5-4134-bf1f-b505642164492024-03-20WarningsExact identifier
application number: M006
Blemish Control Dots aloe veraSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.4722ff71-7d9f-4ef2-9f8b-3614e80b864f2024-03-20WarningsExact identifier
application number: M006
Blemish Control DotsSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.dc5410d0-d9f0-4ea4-b587-8bdfc39ac92b2024-03-20WarningsExact identifier
application number: M006
Blemish DotsSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.ca0e6b50-2995-41f8-b944-9f166aac05112024-03-13WarningsExact identifier
application number: M006
Maximum Sterngth Cleansing Pads EquateSALICYLIC ACIDWalmart7db929b6-6470-4840-b016-7e19688548dd2024-03-11WarningsExact identifier
application number: M006
Acne Body WashSALICYLIC ACIDRejoice International97369cca-735a-425f-a0bc-00bc076914652024-02-28WarningsExact identifier
application number: M006
Oil-Free Foaming Acne Wash Facial Cleanser GrapefruitSALICYLIC ACIDRejoice Internationala31baa57-1dfd-44d6-87a5-1b06377cb8b92024-02-28WarningsExact identifier
application number: M006
Oil-Free Foaming Acne Wash Facial Cleanser Tea Tree OilSALICYLIC ACIDRejoice International7ae434d1-8b07-4121-9163-df07598d41562024-02-28WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317152salicylic acid 2 % Topical CreamPSNcfe76456-0a4c-4dd8-b060-af9d109fb9b94
317152salicylic acid 20 MG/ML Topical CreamSCDcfe76456-0a4c-4dd8-b060-af9d109fb9b94
317152salicylic acid 2 % Topical CreamSYcfe76456-0a4c-4dd8-b060-af9d109fb9b94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
78863-1090-1788631090011 BOTTLE, DISPENSING in 1 CARTON (78863-1090-1) / 50 g in 1 BOTTLE, DISPENSING2020-05-010000-00-00NoNoCurrent